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The Infrared Thermometer (Model: PC808) is intermittent measurement of ear and forehead temperature at home. It can be used for anybody, e.g. for new-born, for children and for adults. The thermometer is touch for the forehead measurement site.

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I am sorry, but the provided text does not contain detailed information about the acceptance criteria, specific test results, sample sizes, expert qualifications, or study methodologies for a device's performance. The document is an FDA 510(k) clearance letter for an Infrared Thermometer, model: PC808, stating that the device is substantially equivalent to legally marketed predicate devices.

The document discusses:

• The FDA's review of the premarket notification.
• The device name and model.
• The regulation number and name for clinical electronic thermometers.
• The regulatory class (Class II).
• Indications for Use: intermittent measurement of ear and forehead temperature at home for anybody (newborn, children, adults), with touch for forehead measurement.
• Type of Use: Over-The-Counter Use.
• General controls provisions of the Act that the manufacturer must comply with.

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Information about experts used to establish ground truth.
• Adjudication methods.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• Standalone algorithm performance.
• The type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This type of detailed performance data is typically found in the full 510(k) submission, not in the clearance letter itself.

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